Pharmacovigilance

Our pharmacovigilance support ranges from full, 24/7 assistance service with global coverage, to tailored services based on client needs.

Medical Monitoring

Biomapas Medical Monitoring team consist of highly experienced licensed medics who have gathered significant amount of experience in various therapeutic areas throughout the years in Phase I-IV studies.

According to Sponsor needs Biomapas Medical Monitors are able to provide following services:

  • Primary Medical Monitors and secondary therapeutic field Medical Experts support;
  • Assistance for PM in development therapeutic area, investigational product and protocol trainings;
  • Assistance for PM in identifying the key risks to data critical to the primary objective and provision of medical input into risk mitigation strategies;
  • Medical Monitoring Plan development;
  • 24/7 coverage medical monitoring;
  • Medical Monitor oversight and support to study team, investigators and sites;
  • Assurance of safety and quality by assisting in protocol interpretation, laboratory and ECG surveillance;
  • Medical input into adverse event handling, including review of cumulative SAE listings and any other emergent safety information;
  • Review of the clinical data and critical parameters of the study;
  • Provision of input in corrective actions plans;
  • Medical coding of AEs and medications;
  • Investigator / site education (Preparation of training material for Investigators, attendance at Investigators Meeting);
  • Provision of medical input in regulatory submissions, if required.

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

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